Notificaciones De Seguridad De Campo acerca de Paradigm reservoirs

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices (HALMED) has received an information from the holder of the enrolment into the medical device registry, Oktal Pharma d.o.o., Zagreb and retrospectively the information from the manufacturer’ representative, Medtronic B.V./Adriatic Region Zagreb about the corrective measures related to the Paradigm infusion sets manufactured by Medtronic MiniMed, USA.
The information is related to the following medical devices:
The manufacturer of the medical device Paradigm reservoirs has identified that certain models of this product may leak, due to a manufacturing defect, which may result in under delivery of insulin and failure. In addition, the manufacturer of the medical device Paradigm infusion sets used with insulin pumps has identified a potential safety issue if insulin or other fluids come in contact with the inside of the Medtronic Paradigm insulin infusion set’s connector. This is most likely to occur after the insulin reservoir is filled. If this occurs, fluid can temporarily block the vents in the connector that allow the pump to prime before use. This can result in too much or too little insulin being delivered to the patient, which can cause hypoglycaemia or hyperglycaemia and require immediate medical attention.
The holder of the entering into the medical device registry, Oktal Pharma d.o.o., Zagreb, has in collaboration with the manufacturer’s representative Medtronic B.V./Adrioatic Region, Zagreb and manufacturer, Medtronic MiniMed, USA, initiated two corrective safety measures resulting in a preventive recall of certain lots of the medical device Paradigm reservoirs with lot numbers MMT326A and MMT-332A and providing further information and advice to healthcare professionals and users of the Paradigm infusion sets about the possibility of under- or over-delivery of insulin or other liquids coming in contact with the inside of the Medtronic Paradigm insulin infusion set’s connector.
The safety information for healthcare professionals and patients related to this recall of certain lots of the medical device is accessible here. The safety information for doctors and patients about the problem of the Paradigm infusion set is accessible here (notice-doctors; notice- patients) (in Croatian).
There was no reported adverse incidents in the Republic of Croatia associated with this problem.